ReActive® Implant 753708Recalls & reported problems
Implant Direct Sybron Manufacturing LLC · Ø3.7 x 8 Platform 3.5mmD · Class 2 · Implant
All models of ReActive Implant (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10841307103585), received between Sep 13, 2019 and Mar 30, 2026 — classified as 21 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (14 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate14
- Positioning Failure3
- Positioning Problem2
- Loss of Osseointegration1
- Osseointegration Problem1
Patient problems
- Failure of Implant18
- Inflammation10
- Unspecified Infection4
- Numbness3
- Osteopenia/ Osteoporosis3
- Pain3
- Sensitivity of Teeth3
- Inadequate Osseointegration2
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Inflammation
MAUDE report 24735818 ↗InjuryMar 30, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 24735584 ↗InjuryDec 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 12, 2023Osseointegration Problem; Osseointegration Problem
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17727478 ↗InjuryJul 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant
MAUDE report 17363465 ↗InjuryJun 6, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 17069451 ↗InjuryJun 6, 2023Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Osteopenia/ Osteoporosis
MAUDE report 17069442 ↗InjuryOct 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 15667066 ↗InjuryAug 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 15319566 ↗InjuryMay 27, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, THERE WAS AN ERROR IN SURGICAL PROTOCOL AND DROPPED FROM THE IMPLANT DRIVER.
Patient problems: Failure of Implant
MAUDE report 14521892 ↗InjuryMay 27, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, THERE WAS AN ERROR IN SURGICAL PROTOCOL AND DROPPED FROM THE IMPLANT DRIVER.
Patient problems: Failure of Implant
MAUDE report 14521891 ↗InjuryMay 27, 2022Positioning Failure; Positioning Failure
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, THERE WAS AN ERROR IN SURGICAL PROTOCOL AND DROPPED FROM THE IMPLANT DRIVER.
Patient problems: Failure of Implant
MAUDE report 14521886 ↗InjuryApr 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Numbness; Pain; Sensitivity of Teeth; Unspecified Infection
MAUDE report 14022345 ↗InjuryApr 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Numbness; Pain; Sensitivity of Teeth; Unspecified Infection
MAUDE report 14022341 ↗InjuryApr 6, 2022Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Inflammation; Numbness; Pain; Sensitivity of Teeth; Unspecified Infection
MAUDE report 14022331 ↗InjuryMay 12, 2021Positioning Problem; Positioning Problem
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 11815594 ↗InjuryApr 9, 2021Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO OSSEOINTEGRATE.
Patient problems: Failure of Implant; Fibrosis; Inflammation
MAUDE report 11641468 ↗InjuryFeb 7, 2020Positioning Problem; Positioning Problem
(B)(4), PATIENT EXPERIENCED LACK OF PRIMARY STABILITY.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9680557 ↗InjuryJan 24, 2020Loss of Osseointegration; Loss of Osseointegration
PER COMPLAINT (B)(4), PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; No Consequences Or Impact To Patient
MAUDE report 9626607 ↗InjuryJan 22, 2020Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING LABORATORY PROCEDURE, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis
MAUDE report 9614686 ↗InjurySep 13, 2019Failure to Osseointegrate; Failure to Osseointegrate
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, IT WAS OBSERVED THAT PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Patient problems: Failure of Implant; Inflammation
MAUDE report 9022226 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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